GUDIDData
eudamed_udi Primary ID: 08680542900819

Epicare comfort plus (UDI 08680542900819)

Manufactured by Arden Medical

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Epicare comfort plus - Primary ID 08680542900819

Device Regulatory Overview

The Epicare comfort plus (Model/Catalog Number: 3920-M) is a medical device manufactured by Arden Medical. This product is indexed under FDA Product Code / Category Classification Y060615 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
3920-M
Product Code / EMDN
Y060615
Device Name
ELBOW ORTHOSES
Database Sync Date
2026-08-09 16:28:55

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

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Frequently Asked Questions

Who is the primary manufacturer of Epicare comfort plus?

The registered manufacturer of record for Epicare comfort plus is Arden Medical.

What is the Primary UDI-DI identifier for Epicare comfort plus?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08680542900819.

What classification code is assigned to this device?

This device is registered under product classification code Y060615.

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